Recruiter: Ines Somorai
Regulatory Affairs Learner, South Africa
Purpose Statement
Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registration and new regulations from government body.
Key Responsibilities
- Manage product registration and approval processes for local and export markets (South Africa, Kenya, Ghana, Botswana, Ivory Coast, Tanzania).
- Prepare and coordinate submission documentation with distributors, competent authorities, and authorized representatives.
- Track registration statuses and facilitate product releases with the global team and supply chain.
- Ensure compliance with South African regulations (SAHPRA, ICASA, DOH) and manage amendments and registrations accordingly.
- Communicate regulatory updates and changes to relevant internal and external stakeholders.
- Review and approve promotional materials to ensure compliance with marketing codes and regulations.
- Maintain and update regulatory SOPs, records, and change notifications.
- Support post-market activities including incident reporting and closure with regulatory authorities.
- Provide regulatory documentation for tender bids, audits, market access, and reimbursement applications.
- Ensure regulatory training compliance and maintain up-to-date records for audits.
- Bachelors degree in Health Science, Microbiology, Biochemistry, Chemistry, or related field.
- Masters degree or relevant certification is highly advantageous.
- Strong problem-solving and analytical abilities.
- Flexibility and adaptability to changing environments.
- Excellent interpersonal and communication skills.
- Effective task planning and prioritization.
- Attention to detail and accuracy.
- Technical understanding of regulatory and product-related issues.
- Teamwork and collaboration skills.
- Proficiency in MS Word, Excel, PowerPoint, email, and internet tools.
